K. Pramod

Novel gene delivery systems

Gene therapy is an emerging field in medical and pharmaceutical sciences because of its potential in treating chronic diseases like cancer, viral infections, myocardial infarctions, and genetic disorders. Application of gene therapy is limited because of lack of suitable methods for proper introduction of genes into cells and therefore, this is an area of interest for most of the researchers. To achieve successful gene therapy, development of proper gene delivery systems could be one of the most important factors. Several nonviral and viral gene transfer methods have been developed. Even though the viral agents have a high transferring efficiency, they are difficult to handle due to their toxicity. To overcome the safety problems of the viral counterpart, several nonviral in vitro and in vivo gene delivery systems are developed. Out of these, the most promising and latest systems include polymer-based nonviral gene carriers, dendrimers, and physical means like electroporation, microinjection, etc., Shunning of possible immunogenicity and toxicity, and the feasibility of repeated administration are some of the merits of nonviral gene delivery systems over viral gene delivery. An ideal nonviral gene carrying system should possess all these merits without any compromise to its gene transferring efficiency. The viral gene delivery systems include lytic and nonlytic vectors for drug delivery. Inspite of its toxicity they are still preferred because of their long term expression, stability, and integrity. This review explores the recent developments and relevancy of the novel gene delivery systems in gene therapy.

Herbal Remedies for the Treatment of Periodontal Disease - A Patent Review

Periodontal diseases, if left unchecked, can lead to major health problems. There are a number of traditional herbal remedies for the treatment and management of diseases related to teeth, gum and oral hygiene. Use of clove oil is an age old remedy still practiced for periodontal problems. Our aim is to present an overall view of the current strategies adopted for the formulation and application of traditional herbal remedies. The article provides a review of the patents obtained on herbal remedies for the treatment of periodontal diseases. In addition, it also provides an overall view of potent herbal remedies widely used for periodontal diseases.

Pharmaceutical product development: A quality by design approach.

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

Unveiling the compatibility of eugenol with formulation excipients by systematic drug-excipient compatibility studies

BackgroundThe drug-excipient compatibility studies were carried out with the possible excipients viz. Tween 80, Carbopol 940, chitosan, sodium alginate, and polycaprolactone (PCL) for their possible use in the formulation of eugenol loaded nanoemulsion gels and nanoparticles.MethodsThe eugenol-excipient compatibility studies were carried out by visual observations, differential scanning calorimetry (DSC), infrared spectroscopy (FTIR), and high-performance thin-layer chromatography (HPTLC).ResultsNo notable change was observed in the samples on visual observation. From the results of the DSC studies, to a much extent, it was assumed that eugenol was not subjected to any interaction with the selected excipients for the proposed nanoemulsion gel and nanoparticles. But in some cases viz. polycaprolactone and Carbopol, though not to a significant level, slight deviation of the nature and position of the endothermic peaks of eugenol were observed. The results of the IR spectroscopy confirmed the compatibility of eugenol with Tween 80, Carbopol 940, chitosan, sodium alginate, and polycaprolactone. The retention factor of the HPTLC densitogram peaks for all the physical mixtures was well within the retention factor (Rf) value range observed for pure eugenol.ConclusionsThe study results confirmed that eugenol is compatible with the selected excipients for the development of nanoemulsion gels and nanoparticles.

Near-Infrared Spectroscopy for Nondestructive Evaluation of Tablets

A nondestructive evaluation of tablets is possible with the application of near-infrared spectroscopy and appropriate statistical techniques. Tablet hardness, disintegration time, dissolution, drug and excipient content, particle size, identification of actives and/or excipients, etc. are possible with the help of near-infrared spectroscopy. The established methods using this technique are rapid and simple. The technique also has found its place in quality assurance and quality control of tablets. It has been suggested as a useful method for the real time in-process testing and is a valuable process analytical technology tool.